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Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial.

Publication ,  Journal Article
Kahn, SR; Shapiro, S; Wells, PS; Rodger, MA; Kovacs, MJ; Anderson, DR; Tagalakis, V; Houweling, AH; Ducruet, T; Holcroft, C; Johri, M; Yeo, E ...
Published in: Lancet
March 8, 2014

BACKGROUND: Post-thrombotic syndrome (PTS) is a common and burdensome complication of deep venous thrombosis (DVT). Previous trials suggesting benefit of elastic compression stockings (ECS) to prevent PTS were small, single-centre studies without placebo control. We aimed to assess the efficacy of ECS, compared with placebo stockings, for the prevention of PTS. METHODS: We did a multicentre randomised placebo-controlled trial of active versus placebo ECS used for 2 years to prevent PTS after a first proximal DVT in centres in Canada and the USA. Patients were randomly assigned to study groups with a web-based randomisation system. Patients presenting with a first symptomatic, proximal DVT were potentially eligible to participate. They were excluded if the use of compression stockings was contraindicated, they had an expected lifespan of less than 6 months, geographical inaccessibility precluded return for follow-up visits, they were unable to apply stockings, or they received thrombolytic therapy for the initial treatment of acute DVT. The primary outcome was PTS diagnosed at 6 months or later using Ginsberg's criteria (leg pain and swelling of ≥1 month duration). We used a modified intention to treat Cox regression analysis, supplemented by a prespecified per-protocol analysis of patients who reported frequent use of their allocated treatment. This study is registered with ClinicalTrials.gov, number NCT00143598, and Current Controlled Trials, number ISRCTN71334751. FINDINGS: From 2004 to 2010, 410 patients were randomly assigned to receive active ECS and 396 placebo ECS. The cumulative incidence of PTS was 14·2% in active ECS versus 12·7% in placebo ECS (hazard ratio adjusted for centre 1·13, 95% CI 0·73-1·76; p=0·58). Results were similar in a prespecified per-protocol analysis of patients who reported frequent use of stockings. INTERPRETATION: ECS did not prevent PTS after a first proximal DVT, hence our findings do not support routine wearing of ECS after DVT. FUNDING: Canadian Institutes of Health Research.

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Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

March 8, 2014

Volume

383

Issue

9920

Start / End Page

880 / 888

Location

England

Related Subject Headings

  • Venous Thrombosis
  • United States
  • Treatment Outcome
  • Stockings, Compression
  • Severity of Illness Index
  • Risk Factors
  • Recurrence
  • Postthrombotic Syndrome
  • Middle Aged
  • Male
 

Citation

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Kahn, S. R., Shapiro, S., Wells, P. S., Rodger, M. A., Kovacs, M. J., Anderson, D. R., … SOX trial investigators, . (2014). Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet, 383(9920), 880–888. https://doi.org/10.1016/S0140-6736(13)61902-9
Kahn, Susan R., Stan Shapiro, Philip S. Wells, Marc A. Rodger, Michael J. Kovacs, David R. Anderson, Vicky Tagalakis, et al. “Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial.Lancet 383, no. 9920 (March 8, 2014): 880–88. https://doi.org/10.1016/S0140-6736(13)61902-9.
Kahn SR, Shapiro S, Wells PS, Rodger MA, Kovacs MJ, Anderson DR, et al. Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet. 2014 Mar 8;383(9920):880–8.
Kahn, Susan R., et al. “Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial.Lancet, vol. 383, no. 9920, Mar. 2014, pp. 880–88. Pubmed, doi:10.1016/S0140-6736(13)61902-9.
Kahn SR, Shapiro S, Wells PS, Rodger MA, Kovacs MJ, Anderson DR, Tagalakis V, Houweling AH, Ducruet T, Holcroft C, Johri M, Solymoss S, Miron M-J, Yeo E, Smith R, Schulman S, Kassis J, Kearon C, Chagnon I, Wong T, Demers C, Hanmiah R, Kaatz S, Selby R, Rathbun S, Desmarais S, Opatrny L, Ortel TL, Ginsberg JS, SOX trial investigators. Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet. 2014 Mar 8;383(9920):880–888.
Journal cover image

Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

March 8, 2014

Volume

383

Issue

9920

Start / End Page

880 / 888

Location

England

Related Subject Headings

  • Venous Thrombosis
  • United States
  • Treatment Outcome
  • Stockings, Compression
  • Severity of Illness Index
  • Risk Factors
  • Recurrence
  • Postthrombotic Syndrome
  • Middle Aged
  • Male